QA Associate for GMP Manufacturing & Documentation

NC State University

Chapel Hill (NC)

On-site

USD 60,000 - 75,000

Full time

14 days+

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Job summary

NC State University seeks a Temporary Quality Assurance Associate to support QA/QC in a regulated manufacturing environment. You will oversee document control, batch record reviews, deviations, CAPA, and validation activities while tracking KPIs and ensuring material release compliance.

The role emphasizes technical writing, collaboration, and training of QA/QC staff on quality systems and SOPs. Prior GMP experience is valued.

Qualifications

Bachelor of Science in Biology, Chemistry, Bioengineering, or related scientific discipline; equivalent experience considered.
2–3 years in QA/QC within a regulated manufacturing environment (GMP).
Experience with batch record review, document control, and technical writing (SOPs, worksheets).
Experience initiating deviations and documenting non-conformances.
Ability to complete EHS modules and annual competencies.

Responsibilities

Provide direction for quality processes and set expectations for facility employees.
Manage and archive controlled documents.
Assist in creation and review of batch records and process forms.
Initiate deviations and implement CAPAs to improve processes.
Direct validation efforts and ensure alignment with project plans.
Track QA metrics and KPIs through audits and error trend analysis.
Inspect incoming materials for compliance with specs.
Write policies, SOPs, forms, and job aids.
Collaborate with teams and train QA/QC staff on quality systems.